Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137993
• Other study ID #: CJ_OLZ_401
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2014
• Last updated: May 11, 2014
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• 20 years to 65 years

• Schizophrenia patient with an acute exacerbation

• Understand the requirement of the study and voluntarily consent to participate in the study

Exclusion Criteria:

• Patients who have another psychiatric disorders

• Patients who have unstable medical conditions

• Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit

• Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)

• Patients who have a history of an allergic reaction to olanzapine

• Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.

• Patient who take clozapine within 12 weeks before screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

Drug:
• A-prexa
A-prexa 5-20 mg for 6 weeks
• Zyprexa
Zyprexa 5-20 mg for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline at 6 week in total PANSS score		6 week	No
Secondary	Change from baseline at 1, 2, 4 and 6 week in total PANSS score.		6 week	No
Secondary	Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week		6 week	No
Secondary	Change from baseline at 6 week in total CGI-S score		6 week	No
Secondary	Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'		6 week	No